Trial Outcomes & Findings for EntrestoTM (LCZ696) In Advanced Heart Failure (LIFE Study) (NCT NCT02816736)
NCT ID: NCT02816736
Last Updated: 2021-12-03
Results Overview
The proportional change from baseline in the AUC for NT-proBNP levels measured at 2, 4, 8, 12, and 24 weeks. AUC was normalized for time and divided by the baseline value of NTproBNP so it has no unitshas no units. With the log-scale, the value of 0 indicates, on average, no change in NTproBNP from baseline. A value \> 0 indicates an increase in log NT Pro BNP relative to baseline and a value \< 0 indicates a decrease in log NT Pro BNP relative to baseline.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
365 participants
Primary outcome timeframe
Baseline, 2, 4, 8, 12, and 24 weeks
Results posted on
2021-12-03
Participant Flow
Participant milestones
| Measure |
LCZ696 (Entresto) + Placebo
LCZ696 50 mg, 100 mg, or 200 mg orally twice daily for 24 weeks, plus valsartan placebo (to match 40 mg, 80 mg, or 160 mg) orally twice daily for 24 weeks
LCZ696: Subjects previously taking no or low-dose ACEI or ARB, or who have an eGFR \< 30 mL/min/1.73m²: starting dose of LCZ696 = 50 mg po BID.
Subjects taking an ARB at greater than low dose: starting dose of LCZ696 = 100 mg po BID.
Subjects taking an ACEI at greater than low dose: starting dose of LCZ696 = 100 mg po BID.
\* At Investigator discretion, study drug may be started at the low dose if there are any concerns regarding tolerability.
Dose adjustments will be performed every 2 weeks by doubling the dose of LCZ696 up to the target max dose of 200 mg po BID as tolerated.
The doses of LCZ696 are 50mg (one low-dose (50mg) tablet), 100mg (one high-dose (100mg) tablet), and 200mg (two high-dose (100mg) tablets.) These doses are equivalent to 24/26 mg, 49/51 mg, and 97/103 mg commercial Entresto™, respectively.
valsartan placebo: Valsartan placebo tablets will be supplied to match the low-dose (40mg) and high-dose (80mg) active valsartan tablets. Dosing for valsartan placebo will mirror dosing for active LCZ696 (the same number of low or high-dose tablets will be given.)
|
Valsartan + Placebo
valsartan 40 mg, 80 mg, or 160 mg orally twice daily for 24 weeks, plus LCZ696 placebo (to match 50 mg, 100 mg, or 200 mg) orally twice daily for 24 weeks
valsartan: Subjects previously taking no or low-dose ACEI or ARB, or who have an eGFR \< 30 mL/min/1.73m²: the starting dose of valsartan = 40 mg po BID.
Subjects taking an ARB at greater than low dose: starting dose of valsartan = 80 mg po BID.
Subjects taking an ACEI at greater than low dose: starting dose of valsartan = 80 mg po BID.
\* At Investigator discretion, study drug may be started at the low dose if there are any concerns regarding tolerability.
Dose adjustments will be performed every 2 weeks by doubling the dose of valsartan up to the target maximum dose of 160 mg po BID, as tolerated.
The doses of valsartan are 40mg (one low-dose (40mg) tablet), 80mg (one high-dose (80mg) tablet), and 160mg (two high-dose (80mg) tablets).
LCZ696 placebo: LCZ696 placebo tablets will be supplied to match the low-dose (50mg) and high-dose (100mg) active LCZ696 tablets. Dosing for LCZ696 placebo will mirror dosing for active valsartan (the same number of low or high-dose tablets will be given.)
|
|---|---|---|
|
Overall Study
STARTED
|
179
|
186
|
|
Overall Study
COMPLETED
|
164
|
166
|
|
Overall Study
NOT COMPLETED
|
15
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
EntrestoTM (LCZ696) In Advanced Heart Failure (LIFE Study)
Baseline characteristics by cohort
| Measure |
LCZ696 (Entresto) + Placebo
n=179 Participants
LCZ696 50 mg, 100 mg, or 200 mg orally twice daily for 24 weeks, plus valsartan placebo (to match 40 mg, 80 mg, or 160 mg) orally twice daily for 24 weeks
LCZ696: Subjects previously taking no or low-dose ACEI or ARB, or who have an eGFR \< 30 mL/min/1.73m²: starting dose of LCZ696 = 50 mg po BID.
Subjects taking an ARB at greater than low dose: starting dose of LCZ696 = 100 mg po BID.
Subjects taking an ACEI at greater than low dose: starting dose of LCZ696 = 100 mg po BID.
\* At Investigator discretion, study drug may be started at the low dose if there are any concerns regarding tolerability.
Dose adjustments will be performed every 2 weeks by doubling the dose of LCZ696 up to the target max dose of 200 mg po BID as tolerated.
The doses of LCZ696 are 50mg (one low-dose (50mg) tablet), 100mg (one high-dose (100mg) tablet), and 200mg (two high-dose (100mg) tablets.) These doses are equivalent to 24/26 mg, 49/51 mg, and 97/103 mg commercial Entresto™, respectively.
valsartan placebo: Valsartan placebo tablets will be supplied to match the low-dose (40mg) and high-dose (80mg) active valsartan tablets. Dosing for valsartan placebo will mirror dosing for active LCZ696 (the same number of low or high-dose tablets will be given.)
|
Valsartan + Placebo
n=186 Participants
valsartan 40 mg, 80 mg, or 160 mg orally twice daily for 24 weeks, plus LCZ696 placebo (to match 50 mg, 100 mg, or 200 mg) orally twice daily for 24 weeks
valsartan: Subjects previously taking no or low-dose ACEI or ARB, or who have an eGFR \< 30 mL/min/1.73m²: the starting dose of valsartan = 40 mg po BID.
Subjects taking an ARB at greater than low dose: starting dose of valsartan = 80 mg po BID.
Subjects taking an ACEI at greater than low dose: starting dose of valsartan = 80 mg po BID.
\* At Investigator discretion, study drug may be started at the low dose if there are any concerns regarding tolerability.
Dose adjustments will be performed every 2 weeks by doubling the dose of valsartan up to the target maximum dose of 160 mg po BID, as tolerated.
The doses of valsartan are 40mg (one low-dose (40mg) tablet), 80mg (one high-dose (80mg) tablet), and 160mg (two high-dose (80mg) tablets).
LCZ696 placebo: LCZ696 placebo tablets will be supplied to match the low-dose (50mg) and high-dose (100mg) active LCZ696 tablets. Dosing for LCZ696 placebo will mirror dosing for active valsartan (the same number of low or high-dose tablets will be given.)
|
Total
n=365 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.0 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
58.8 years
STANDARD_DEVIATION 13.0 • n=7 Participants
|
59.4 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
126 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
262 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
172 Participants
n=5 Participants
|
173 Participants
n=7 Participants
|
345 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
67 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
107 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
222 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
179 Participants
n=5 Participants
|
186 Participants
n=7 Participants
|
365 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2, 4, 8, 12, and 24 weeksPopulation: All randomized patients with baseline and at least one post-baseline NTpro BNP value present were included. Population was further reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
The proportional change from baseline in the AUC for NT-proBNP levels measured at 2, 4, 8, 12, and 24 weeks. AUC was normalized for time and divided by the baseline value of NTproBNP so it has no unitshas no units. With the log-scale, the value of 0 indicates, on average, no change in NTproBNP from baseline. A value \> 0 indicates an increase in log NT Pro BNP relative to baseline and a value \< 0 indicates a decrease in log NT Pro BNP relative to baseline.
Outcome measures
| Measure |
LCZ696 (Entresto) + Placebo
n=155 Participants
LCZ696 50 mg, 100 mg, or 200 mg orally twice daily for 24 weeks, plus valsartan placebo (to match 40 mg, 80 mg, or 160 mg) orally twice daily for 24 weeks
LCZ696: Subjects previously taking no or low-dose ACEI or ARB, or who have an eGFR \< 30 mL/min/1.73m²: starting dose of LCZ696 = 50 mg po BID.
Subjects taking an ARB at greater than low dose: starting dose of LCZ696 = 100 mg po BID.
Subjects taking an ACEI at greater than low dose: starting dose of LCZ696 = 100 mg po BID.
\* At Investigator discretion, study drug may be started at the low dose if there are any concerns regarding tolerability.
Dose adjustments will be performed every 2 weeks by doubling the dose of LCZ696 up to the target max dose of 200 mg po BID as tolerated.
The doses of LCZ696 are 50mg (one low-dose (50mg) tablet), 100mg (one high-dose (100mg) tablet), and 200mg (two high-dose (100mg) tablets.) These doses are equivalent to 24/26 mg, 49/51 mg, and 97/103 mg commercial Entresto™, respectively.
valsartan placebo: Valsartan placebo tablets will be supplied to match the low-dose (40mg) and high-dose (80mg) active valsartan tablets. Dosing for valsartan placebo will mirror dosing for active LCZ696 (the same number of low or high-dose tablets will be given.)
|
Valsartan + Placebo
n=158 Participants
valsartan 40 mg, 80 mg, or 160 mg orally twice daily for 24 weeks, plus LCZ696 placebo (to match 50 mg, 100 mg, or 200 mg) orally twice daily for 24 weeks
valsartan: Subjects previously taking no or low-dose ACEI or ARB, or who have an eGFR \< 30 mL/min/1.73m²: the starting dose of valsartan = 40 mg po BID.
Subjects taking an ARB at greater than low dose: starting dose of valsartan = 80 mg po BID.
Subjects taking an ACEI at greater than low dose: starting dose of valsartan = 80 mg po BID.
\* At Investigator discretion, study drug may be started at the low dose if there are any concerns regarding tolerability.
Dose adjustments will be performed every 2 weeks by doubling the dose of valsartan up to the target maximum dose of 160 mg po BID, as tolerated.
The doses of valsartan are 40mg (one low-dose (40mg) tablet), 80mg (one high-dose (80mg) tablet), and 160mg (two high-dose (80mg) tablets).
LCZ696 placebo: LCZ696 placebo tablets will be supplied to match the low-dose (50mg) and high-dose (100mg) active LCZ696 tablets. Dosing for LCZ696 placebo will mirror dosing for active valsartan (the same number of low or high-dose tablets will be given.)
|
|---|---|---|
|
Change in NT-proBNP
|
0.14 unitless
Standard Deviation 0.65
|
0.19 unitless
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: Randomization through 24 weeksPopulation: Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
Composite endpoint of effects of LCZ696 compared to valsartan over 24 weeks will be compared based upon the number of days subjects are * alive and out of hospital * not listed for transplant (Status 1A, 1B or 1-4), or undergoing transplant * not implanted with an LVAD * not maintained or started on continuous inotropic therapy for ≥ 7 days * not hospitalized twice for HF (following the index admission) The days alive and out of hospital will end on the day of the second HF readmission, if applicable.
Outcome measures
| Measure |
LCZ696 (Entresto) + Placebo
n=167 Participants
LCZ696 50 mg, 100 mg, or 200 mg orally twice daily for 24 weeks, plus valsartan placebo (to match 40 mg, 80 mg, or 160 mg) orally twice daily for 24 weeks
LCZ696: Subjects previously taking no or low-dose ACEI or ARB, or who have an eGFR \< 30 mL/min/1.73m²: starting dose of LCZ696 = 50 mg po BID.
Subjects taking an ARB at greater than low dose: starting dose of LCZ696 = 100 mg po BID.
Subjects taking an ACEI at greater than low dose: starting dose of LCZ696 = 100 mg po BID.
\* At Investigator discretion, study drug may be started at the low dose if there are any concerns regarding tolerability.
Dose adjustments will be performed every 2 weeks by doubling the dose of LCZ696 up to the target max dose of 200 mg po BID as tolerated.
The doses of LCZ696 are 50mg (one low-dose (50mg) tablet), 100mg (one high-dose (100mg) tablet), and 200mg (two high-dose (100mg) tablets.) These doses are equivalent to 24/26 mg, 49/51 mg, and 97/103 mg commercial Entresto™, respectively.
valsartan placebo: Valsartan placebo tablets will be supplied to match the low-dose (40mg) and high-dose (80mg) active valsartan tablets. Dosing for valsartan placebo will mirror dosing for active LCZ696 (the same number of low or high-dose tablets will be given.)
|
Valsartan + Placebo
n=168 Participants
valsartan 40 mg, 80 mg, or 160 mg orally twice daily for 24 weeks, plus LCZ696 placebo (to match 50 mg, 100 mg, or 200 mg) orally twice daily for 24 weeks
valsartan: Subjects previously taking no or low-dose ACEI or ARB, or who have an eGFR \< 30 mL/min/1.73m²: the starting dose of valsartan = 40 mg po BID.
Subjects taking an ARB at greater than low dose: starting dose of valsartan = 80 mg po BID.
Subjects taking an ACEI at greater than low dose: starting dose of valsartan = 80 mg po BID.
\* At Investigator discretion, study drug may be started at the low dose if there are any concerns regarding tolerability.
Dose adjustments will be performed every 2 weeks by doubling the dose of valsartan up to the target maximum dose of 160 mg po BID, as tolerated.
The doses of valsartan are 40mg (one low-dose (40mg) tablet), 80mg (one high-dose (80mg) tablet), and 160mg (two high-dose (80mg) tablets).
LCZ696 placebo: LCZ696 placebo tablets will be supplied to match the low-dose (50mg) and high-dose (100mg) active LCZ696 tablets. Dosing for LCZ696 placebo will mirror dosing for active valsartan (the same number of low or high-dose tablets will be given.)
|
|---|---|---|
|
Composite Endpoint of the Effects of LCZ696 (Number of Days)
|
108.58 days
Interval 95.22 to 121.95
|
119.8 days
Interval 107.64 to 131.96
|
SECONDARY outcome
Timeframe: Randomization through 24 weeksPopulation: Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
Tolerability as measured by number of subjects achieving a target dose of 0% (stopped study drug early or was never started on study drug), 25%, 50% or 100% of valsartan or LCZ696 (based on last dose of study drug taken prior to end of study)
Outcome measures
| Measure |
LCZ696 (Entresto) + Placebo
n=167 Participants
LCZ696 50 mg, 100 mg, or 200 mg orally twice daily for 24 weeks, plus valsartan placebo (to match 40 mg, 80 mg, or 160 mg) orally twice daily for 24 weeks
LCZ696: Subjects previously taking no or low-dose ACEI or ARB, or who have an eGFR \< 30 mL/min/1.73m²: starting dose of LCZ696 = 50 mg po BID.
Subjects taking an ARB at greater than low dose: starting dose of LCZ696 = 100 mg po BID.
Subjects taking an ACEI at greater than low dose: starting dose of LCZ696 = 100 mg po BID.
\* At Investigator discretion, study drug may be started at the low dose if there are any concerns regarding tolerability.
Dose adjustments will be performed every 2 weeks by doubling the dose of LCZ696 up to the target max dose of 200 mg po BID as tolerated.
The doses of LCZ696 are 50mg (one low-dose (50mg) tablet), 100mg (one high-dose (100mg) tablet), and 200mg (two high-dose (100mg) tablets.) These doses are equivalent to 24/26 mg, 49/51 mg, and 97/103 mg commercial Entresto™, respectively.
valsartan placebo: Valsartan placebo tablets will be supplied to match the low-dose (40mg) and high-dose (80mg) active valsartan tablets. Dosing for valsartan placebo will mirror dosing for active LCZ696 (the same number of low or high-dose tablets will be given.)
|
Valsartan + Placebo
n=168 Participants
valsartan 40 mg, 80 mg, or 160 mg orally twice daily for 24 weeks, plus LCZ696 placebo (to match 50 mg, 100 mg, or 200 mg) orally twice daily for 24 weeks
valsartan: Subjects previously taking no or low-dose ACEI or ARB, or who have an eGFR \< 30 mL/min/1.73m²: the starting dose of valsartan = 40 mg po BID.
Subjects taking an ARB at greater than low dose: starting dose of valsartan = 80 mg po BID.
Subjects taking an ACEI at greater than low dose: starting dose of valsartan = 80 mg po BID.
\* At Investigator discretion, study drug may be started at the low dose if there are any concerns regarding tolerability.
Dose adjustments will be performed every 2 weeks by doubling the dose of valsartan up to the target maximum dose of 160 mg po BID, as tolerated.
The doses of valsartan are 40mg (one low-dose (40mg) tablet), 80mg (one high-dose (80mg) tablet), and 160mg (two high-dose (80mg) tablets).
LCZ696 placebo: LCZ696 placebo tablets will be supplied to match the low-dose (50mg) and high-dose (100mg) active LCZ696 tablets. Dosing for LCZ696 placebo will mirror dosing for active valsartan (the same number of low or high-dose tablets will be given.)
|
|---|---|---|
|
Tolerability - Target Dose
Not on study drug (0%)
|
49 Participants
|
37 Participants
|
|
Tolerability - Target Dose
Low dose (25%)
|
28 Participants
|
41 Participants
|
|
Tolerability - Target Dose
Mid dose (50%)
|
33 Participants
|
30 Participants
|
|
Tolerability - Target Dose
High dose (100%)
|
57 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: Randomization through 24 weeksPopulation: Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
Tolerability as measured by number of subjects developing hypotension (SBP ≤ 85 mmHg) with symptoms
Outcome measures
| Measure |
LCZ696 (Entresto) + Placebo
n=167 Participants
LCZ696 50 mg, 100 mg, or 200 mg orally twice daily for 24 weeks, plus valsartan placebo (to match 40 mg, 80 mg, or 160 mg) orally twice daily for 24 weeks
LCZ696: Subjects previously taking no or low-dose ACEI or ARB, or who have an eGFR \< 30 mL/min/1.73m²: starting dose of LCZ696 = 50 mg po BID.
Subjects taking an ARB at greater than low dose: starting dose of LCZ696 = 100 mg po BID.
Subjects taking an ACEI at greater than low dose: starting dose of LCZ696 = 100 mg po BID.
\* At Investigator discretion, study drug may be started at the low dose if there are any concerns regarding tolerability.
Dose adjustments will be performed every 2 weeks by doubling the dose of LCZ696 up to the target max dose of 200 mg po BID as tolerated.
The doses of LCZ696 are 50mg (one low-dose (50mg) tablet), 100mg (one high-dose (100mg) tablet), and 200mg (two high-dose (100mg) tablets.) These doses are equivalent to 24/26 mg, 49/51 mg, and 97/103 mg commercial Entresto™, respectively.
valsartan placebo: Valsartan placebo tablets will be supplied to match the low-dose (40mg) and high-dose (80mg) active valsartan tablets. Dosing for valsartan placebo will mirror dosing for active LCZ696 (the same number of low or high-dose tablets will be given.)
|
Valsartan + Placebo
n=168 Participants
valsartan 40 mg, 80 mg, or 160 mg orally twice daily for 24 weeks, plus LCZ696 placebo (to match 50 mg, 100 mg, or 200 mg) orally twice daily for 24 weeks
valsartan: Subjects previously taking no or low-dose ACEI or ARB, or who have an eGFR \< 30 mL/min/1.73m²: the starting dose of valsartan = 40 mg po BID.
Subjects taking an ARB at greater than low dose: starting dose of valsartan = 80 mg po BID.
Subjects taking an ACEI at greater than low dose: starting dose of valsartan = 80 mg po BID.
\* At Investigator discretion, study drug may be started at the low dose if there are any concerns regarding tolerability.
Dose adjustments will be performed every 2 weeks by doubling the dose of valsartan up to the target maximum dose of 160 mg po BID, as tolerated.
The doses of valsartan are 40mg (one low-dose (40mg) tablet), 80mg (one high-dose (80mg) tablet), and 160mg (two high-dose (80mg) tablets).
LCZ696 placebo: LCZ696 placebo tablets will be supplied to match the low-dose (50mg) and high-dose (100mg) active LCZ696 tablets. Dosing for LCZ696 placebo will mirror dosing for active valsartan (the same number of low or high-dose tablets will be given.)
|
|---|---|---|
|
Tolerability - Hypotension
Yes
|
29 Participants
|
20 Participants
|
|
Tolerability - Hypotension
No
|
138 Participants
|
148 Participants
|
SECONDARY outcome
Timeframe: Randomization through 24 weeksPopulation: Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
Tolerability as measured by number of subjects developing worsening renal function (eGFR \< 20 ml/min/1.73 m²)
Outcome measures
| Measure |
LCZ696 (Entresto) + Placebo
n=167 Participants
LCZ696 50 mg, 100 mg, or 200 mg orally twice daily for 24 weeks, plus valsartan placebo (to match 40 mg, 80 mg, or 160 mg) orally twice daily for 24 weeks
LCZ696: Subjects previously taking no or low-dose ACEI or ARB, or who have an eGFR \< 30 mL/min/1.73m²: starting dose of LCZ696 = 50 mg po BID.
Subjects taking an ARB at greater than low dose: starting dose of LCZ696 = 100 mg po BID.
Subjects taking an ACEI at greater than low dose: starting dose of LCZ696 = 100 mg po BID.
\* At Investigator discretion, study drug may be started at the low dose if there are any concerns regarding tolerability.
Dose adjustments will be performed every 2 weeks by doubling the dose of LCZ696 up to the target max dose of 200 mg po BID as tolerated.
The doses of LCZ696 are 50mg (one low-dose (50mg) tablet), 100mg (one high-dose (100mg) tablet), and 200mg (two high-dose (100mg) tablets.) These doses are equivalent to 24/26 mg, 49/51 mg, and 97/103 mg commercial Entresto™, respectively.
valsartan placebo: Valsartan placebo tablets will be supplied to match the low-dose (40mg) and high-dose (80mg) active valsartan tablets. Dosing for valsartan placebo will mirror dosing for active LCZ696 (the same number of low or high-dose tablets will be given.)
|
Valsartan + Placebo
n=168 Participants
valsartan 40 mg, 80 mg, or 160 mg orally twice daily for 24 weeks, plus LCZ696 placebo (to match 50 mg, 100 mg, or 200 mg) orally twice daily for 24 weeks
valsartan: Subjects previously taking no or low-dose ACEI or ARB, or who have an eGFR \< 30 mL/min/1.73m²: the starting dose of valsartan = 40 mg po BID.
Subjects taking an ARB at greater than low dose: starting dose of valsartan = 80 mg po BID.
Subjects taking an ACEI at greater than low dose: starting dose of valsartan = 80 mg po BID.
\* At Investigator discretion, study drug may be started at the low dose if there are any concerns regarding tolerability.
Dose adjustments will be performed every 2 weeks by doubling the dose of valsartan up to the target maximum dose of 160 mg po BID, as tolerated.
The doses of valsartan are 40mg (one low-dose (40mg) tablet), 80mg (one high-dose (80mg) tablet), and 160mg (two high-dose (80mg) tablets).
LCZ696 placebo: LCZ696 placebo tablets will be supplied to match the low-dose (50mg) and high-dose (100mg) active LCZ696 tablets. Dosing for LCZ696 placebo will mirror dosing for active valsartan (the same number of low or high-dose tablets will be given.)
|
|---|---|---|
|
Tolerability - Renal Function
Yes
|
7 Participants
|
7 Participants
|
|
Tolerability - Renal Function
No
|
160 Participants
|
161 Participants
|
SECONDARY outcome
Timeframe: Randomization through 24 weeksPopulation: Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
Tolerability as measured by number of subjects developing moderate (\>/= 5.5 mmol/L-5.9 mmol/L) or severe (\>/= 6 mmol/L) hyperkalemia
Outcome measures
| Measure |
LCZ696 (Entresto) + Placebo
n=167 Participants
LCZ696 50 mg, 100 mg, or 200 mg orally twice daily for 24 weeks, plus valsartan placebo (to match 40 mg, 80 mg, or 160 mg) orally twice daily for 24 weeks
LCZ696: Subjects previously taking no or low-dose ACEI or ARB, or who have an eGFR \< 30 mL/min/1.73m²: starting dose of LCZ696 = 50 mg po BID.
Subjects taking an ARB at greater than low dose: starting dose of LCZ696 = 100 mg po BID.
Subjects taking an ACEI at greater than low dose: starting dose of LCZ696 = 100 mg po BID.
\* At Investigator discretion, study drug may be started at the low dose if there are any concerns regarding tolerability.
Dose adjustments will be performed every 2 weeks by doubling the dose of LCZ696 up to the target max dose of 200 mg po BID as tolerated.
The doses of LCZ696 are 50mg (one low-dose (50mg) tablet), 100mg (one high-dose (100mg) tablet), and 200mg (two high-dose (100mg) tablets.) These doses are equivalent to 24/26 mg, 49/51 mg, and 97/103 mg commercial Entresto™, respectively.
valsartan placebo: Valsartan placebo tablets will be supplied to match the low-dose (40mg) and high-dose (80mg) active valsartan tablets. Dosing for valsartan placebo will mirror dosing for active LCZ696 (the same number of low or high-dose tablets will be given.)
|
Valsartan + Placebo
n=168 Participants
valsartan 40 mg, 80 mg, or 160 mg orally twice daily for 24 weeks, plus LCZ696 placebo (to match 50 mg, 100 mg, or 200 mg) orally twice daily for 24 weeks
valsartan: Subjects previously taking no or low-dose ACEI or ARB, or who have an eGFR \< 30 mL/min/1.73m²: the starting dose of valsartan = 40 mg po BID.
Subjects taking an ARB at greater than low dose: starting dose of valsartan = 80 mg po BID.
Subjects taking an ACEI at greater than low dose: starting dose of valsartan = 80 mg po BID.
\* At Investigator discretion, study drug may be started at the low dose if there are any concerns regarding tolerability.
Dose adjustments will be performed every 2 weeks by doubling the dose of valsartan up to the target maximum dose of 160 mg po BID, as tolerated.
The doses of valsartan are 40mg (one low-dose (40mg) tablet), 80mg (one high-dose (80mg) tablet), and 160mg (two high-dose (80mg) tablets).
LCZ696 placebo: LCZ696 placebo tablets will be supplied to match the low-dose (50mg) and high-dose (100mg) active LCZ696 tablets. Dosing for LCZ696 placebo will mirror dosing for active valsartan (the same number of low or high-dose tablets will be given.)
|
|---|---|---|
|
Tolerability - Hyperkalemia
Yes
|
28 Participants
|
15 Participants
|
|
Tolerability - Hyperkalemia
No
|
139 Participants
|
153 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomization through 24 weeksTime to death through 24 weeks
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomization through 24 weeksTime to first HF hospitalization through 24 weeks
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomization through 24 weeksTime to death and first HF hospitalization through 24 weeks
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomization through 24 weeksTotal number of HF hospitalization admissions through 24 weeks
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomization through 24 weeksNumber of subjects on continuous inotropic therapy \>/= 7 days after discharge from the index hospitalization through 24 weeks
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomization through 24 weeksNumber of subjects listed for transplant (status 1A, 1B or 1-4), transplanted or implanted with an LVAD through 24 weeks.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomization through 24 weeksChange in eGFR and cystatin C levels compared to baseline. Renal function will be assessed at baseline, 4, 8, 12, and 24 weeks
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomization through 24 weeksNumber of subjects with unanticipated use of IV diuretics (outpatient, ER or inpatient) through 24 weeks.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomization through 24 weeksDifference in AUC of the KCCQ at 4, 12 and 24 weeks
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomization through 24 weeksThe change in AUC for the ratio of NT-proBNP/BNP from baseline to weeks 2, 4, 8, 12 and 24 weeks
Outcome measures
Outcome data not reported
Adverse Events
LCZ696 (Entresto) + Placebo
Serious events: 43 serious events
Other events: 0 other events
Deaths: 13 deaths
Valsartan + Placebo
Serious events: 27 serious events
Other events: 0 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
LCZ696 (Entresto) + Placebo
n=167 participants at risk
LCZ696 50 mg, 100 mg, or 200 mg orally twice daily for 24 weeks, plus valsartan placebo (to match 40 mg, 80 mg, or 160 mg) orally twice daily for 24 weeks
LCZ696: Subjects previously taking no or low-dose ACEI or ARB, or who have an eGFR \< 30 mL/min/1.73m²: starting dose of LCZ696 = 50 mg po BID.
Subjects taking an ARB at greater than low dose: starting dose of LCZ696 = 100 mg po BID.
Subjects taking an ACEI at greater than low dose: starting dose of LCZ696 = 100 mg po BID.
\* At Investigator discretion, study drug may be started at the low dose if there are any concerns regarding tolerability.
Dose adjustments will be performed every 2 weeks by doubling the dose of LCZ696 up to the target max dose of 200 mg po BID as tolerated.
The doses of LCZ696 are 50mg (one low-dose (50mg) tablet), 100mg (one high-dose (100mg) tablet), and 200mg (two high-dose (100mg) tablets.) These doses are equivalent to 24/26 mg, 49/51 mg, and 97/103 mg commercial Entresto™, respectively.
valsartan placebo: Valsartan placebo tablets will be supplied to match the low-dose (40mg) and high-dose (80mg) active valsartan tablets. Dosing for valsartan placebo will mirror dosing for active LCZ696 (the same number of low or high-dose tablets will be given.)
|
Valsartan + Placebo
n=168 participants at risk
valsartan 40 mg, 80 mg, or 160 mg orally twice daily for 24 weeks, plus LCZ696 placebo (to match 50 mg, 100 mg, or 200 mg) orally twice daily for 24 weeks
valsartan: Subjects previously taking no or low-dose ACEI or ARB, or who have an eGFR \< 30 mL/min/1.73m²: the starting dose of valsartan = 40 mg po BID.
Subjects taking an ARB at greater than low dose: starting dose of valsartan = 80 mg po BID.
Subjects taking an ACEI at greater than low dose: starting dose of valsartan = 80 mg po BID.
\* At Investigator discretion, study drug may be started at the low dose if there are any concerns regarding tolerability.
Dose adjustments will be performed every 2 weeks by doubling the dose of valsartan up to the target maximum dose of 160 mg po BID, as tolerated.
The doses of valsartan are 40mg (one low-dose (40mg) tablet), 80mg (one high-dose (80mg) tablet), and 160mg (two high-dose (80mg) tablets).
LCZ696 placebo: LCZ696 placebo tablets will be supplied to match the low-dose (50mg) and high-dose (100mg) active LCZ696 tablets. Dosing for LCZ696 placebo will mirror dosing for active valsartan (the same number of low or high-dose tablets will be given.)
|
|---|---|---|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
1.2%
2/167 • Number of events 2 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/167 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal Haematoma
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.2%
2/167 • Number of events 2 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Skin and subcutaneous tissue disorders
Diabetic ulcer
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Vascular disorders
Haematoma
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Vascular disorders
Hypotension
|
0.00%
0/167 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Vascular disorders
Peripheral Ischaemia
|
0.00%
0/167 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Vascular disorders
Shock Haemorrhagic
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/167 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/167 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
1.2%
2/168 • Number of events 2 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Blood and lymphatic system disorders
Haemorrhagic Anaemia
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/167 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Cardiac disorders
Cardiac Failure
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
1.2%
2/168 • Number of events 2 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/167 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Gastrointestinal disorders
Haematochezia
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Gastrointestinal disorders
Heal Ulcer
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/167 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 2 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Gastrointestinal disorders
Impaired Gastric Emptying
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Gastrointestinal disorders
Large Intestinal Obstruction
|
0.00%
0/167 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
General disorders
Complication Associated With Device
|
0.00%
0/167 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
General disorders
Multiple Organ Dysfunction Syndrome
|
2.4%
4/167 • Number of events 4 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
General disorders
Pyrexia
|
1.2%
2/167 • Number of events 2 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/167 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.00%
0/167 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Immune system disorders
Heart Transplant Rejection
|
0.00%
0/167 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Infections and infestations
Abdominal Abscess
|
0.00%
0/167 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 2 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/167 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Infections and infestations
Arthritis Infective
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Infections and infestations
Bacteraemia
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Infections and infestations
Bacterial Infection
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Infections and infestations
Bronchitis Bacterial
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Infections and infestations
Cellulitis
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Infections and infestations
Device Related Infection
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Infections and infestations
Endocarditis
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/167 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Infections and infestations
Gangrene
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Infections and infestations
Gastroenteritis Bacterial
|
0.00%
0/167 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/167 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Infections and infestations
Infuenza
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Infections and infestations
Ophthalmic herpes Zoster
|
0.00%
0/167 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/167 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Infections and infestations
Pneumonia
|
2.4%
4/167 • Number of events 4 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
1.8%
3/168 • Number of events 3 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Infections and infestations
Pneumonia Klebsiella
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Infections and infestations
Respiratory syncytial Virus Infection
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Infections and infestations
Sepsis
|
1.2%
2/167 • Number of events 3 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Infections and infestations
Septic Shock
|
0.00%
0/167 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
1.2%
2/168 • Number of events 2 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.60%
1/167 • Number of events 2 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/167 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Infections and infestations
Viral Upper Respirator Tract Infection
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.00%
0/167 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Injury, poisoning and procedural complications
Facial bones Fracture
|
0.00%
0/167 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Injury, poisoning and procedural complications
Fall
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Injury, poisoning and procedural complications
Foreign body In Gastrointestinal Tract
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/167 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Investigations
Anticoagulation Drug Level Below Therapeutic
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
2/167 • Number of events 2 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/167 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.00%
0/167 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.2%
2/167 • Number of events 2 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Metabolism and nutrition disorders
Hyperglycaemic Hyperosmolar Nonketotic Syndrome
|
0.00%
0/167 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/167 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/167 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
1.2%
2/168 • Number of events 2 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/167 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/167 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/167 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of Colon
|
1.2%
2/167 • Number of events 2 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma Cell Myeloma
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Adenocarcinoma
|
0.00%
0/167 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Nervous system disorders
Encephalopathy
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Nervous system disorders
Seizure
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Product Issues
Device Dislocation
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Product Issues
Lead Dislodgement
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Psychiatric disorders
Major Depression
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Psychiatric disorders
Mania
|
0.00%
0/167 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Psychiatric disorders
Substance Abuse
|
0.60%
1/167 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.00%
0/168 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
|
Psychiatric disorders
Substance-Induced Psychotic Disorder
|
0.00%
0/167 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
0.60%
1/168 • Number of events 1 • Randomization to week 24
Adverse event collection was limited to those meeting serious criteria; SAEs were assessed at each study visit/phone call conducted. Population was reduced due to impact of COVID-19 by removing patients with inadequate follow-up after Feb 29th, 2020.
|
Other adverse events
Adverse event data not reported
Additional Information
Kevin J. Anstrom, Ph.D., Director of Biostatistics
Duke Clinical Research Institute
Phone: 919-668-8902
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60